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FDA 510(k) clearance

Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October.
Results generated by the algorithm-based software are...

New York-based Peerbridge Health announced that its wireless device, dubbed the Peerbridge Cor System, is the latest ECG device to receive 510(k) clearance from the FDA. According to the company, the device has the smaller on-body footprint of any wearable, multi-channel ECG with water-resistant electrodes.
“The 510(k) clearance of our Peerbridge Cor ECG monitor is an exciting milestone and the...

Redwood City, California-based Carrot has received FDA 510(k) clearance for its Carbon Monoxide Breath Sensor System, an over-the-counter, Bluetooth-enabled device that pairs with a smartphone app and is intended for commercial use in smoking cessation programs.
“Smoking is the number one cause of preventable illness and death worldwide,” Dr. David S. Utley, founder and CEO of Carrot, said in a...

Figuring out what is causing an irregular heartbeat typically means an invasive procedure: most often, electrophysiologists insert a catheter to the heart via an artery or vein to get a cardiac “map” and identify the origin of the arrhythmia. But a new device from Medtronic takes the process outside, in the form of a sensor-enabled vest.
Dubbed the CardioInsight Noninvasive 3D Mapping System, the...

While most wearable baby monitors are designed with the intention to give parents peace of mind, some experts warn they may do just the opposite.
In a recent JAMA article, researchers outlined how the proliferation of baby wearables that monitor vital signs and alert parents of abnormalities via a companion app can cause undue alarm to parents. Moreover, the researchers point out, the devices...

Vancouver, BC-based Clarius Mobile Health has received FDA 510 (k) clearance for its app-based, wireless, handheld ultrasound scanners.
The devices, which are designed for clinicians to quickly conduct scans and guide short procedures at the bedside, are compatible with the latest smartphones and tables both for iOS and Android and are now available for medical professionals on Clarius’s website...

Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes management app called Insulia.
The app, which is designed for people treated with basal insulin, is classified as a prescription-only medical device and will be available to patients and healthcare...

Israel-based medical device maker TytoCare has received FDA 510(k) clearance for its digital stethoscope, joining the company's ecosystem of connected tools for remote medical examinations.
The company also offers several FDA Class 1 devices – a connected otoscope for ear examinations, a high-resolution camera, and a thermometer that uses the forehead to get a reading.
The stethoscope pairs...

Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen.
"FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," CEO Sean Saint, a veteran engineer of Dexcom, Medtronic, and...

Neurometrix has received FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief, the company announced last week.
Like its predecessor, the device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. It's worn around the calf.
“This 510(k) further advances Quell technology by allowing the...